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CompletedNCT04421690COGMAUpdated Mar 15, 2023

Computerized Cognitive Training in Middle-Aged Adults With Generalized Anxiety Disorder: A Pilot Study

An interventional study of Cognitive Training and Trivia Training in Generalized Anxiety Disorder, sponsored by University of Missouri-Columbia. Completed at 1 site in United States. Open to participants aged 45 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-15.

Sponsored by University of Missouri-Columbia · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
45 Years to 59 Years
Sex
All
01

Study summary

The purpose of this research is to look at the effects of computerized cognitive training on anxiety, sleep, mental abilities (cognition), and other aspects of daytime functioning, such as arousal.

02

Conditions studied

  • Generalized Anxiety Disorder

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Keywords

  • Anxiety
  • Middle-Aged
  • Sleep
  • Cognition
  • Older Adults
03

In context

Anxiety Disorders

4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.

This study's enrollment of 30 is below the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

University of Missouri-Columbia is the lead sponsor of 357 studies on the registry; 70 are open to participants now.

Of its 42 completed or terminated interventional studies of FDA-regulated products, 28 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 59 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 45-59 yrs of age
  • no neurological or psychiatric illness, dementia, or loss of consciousness > 5 mins
  • nongamers (i.e., report \<1 hour of video/cognitive training games/week over last 2 yrs)
  • proficient in English (reading and writing)
  • computer meets technology requirements (i.e. Windows: Windows 7 or above using Internet Explorer 11 or Edge, Mozilla Firefox 41 and above, Google Chrome 48 and above; Mac OS: Mac OS X v10.8 and above using Safari 10 and above, Mozilla Firefox 42 and above, Google Chrome 48 and above; Android App: Android 6 or higher version; iOS App: iOS 10 or higher version
  • meet clinical dx criteria for Generalized Anxiety Disorder.

Exclusion criteria

Exclusion Criteria:

  • unable to provide informed consent
  • unable to undergo randomization
  • Telephone Interview for Cognitive Status-modified (TICS) score \<33, 2)
  • other sleep disorder (i.e., sleep apnea, Periodic Limb Movement Disorder-PLMD, narcolepsy, REM Sleep Behavior Disorder)
  • severe untreated psychiatric comorbidity that renders randomization unethical
  • psychotropic, anxiolytic medications or other medications(e.g., beta-blockers) that alter mood or sleep
  • uncorrected visual/auditory impairments
  • participation in nonpharmacological treatment for sleep/fatigue/mood outside the current study.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Cognitive Training

    8 week computerized cognitive training

    Behavioral: Cognitive Training

  • Active comparator
    Trivia Training

    8 week computerized trivia training

    Behavioral: Trivia Training

Interventions

  • BehavioralCognitive Training

    Participants (n=15) will complete computerized cognitive training games and activities online 3 times/week for 8 weeks.

  • BehavioralTrivia Training

    Participants (n=15) will receive computerized trivia questions to answer and submit 3 times/week for 8 weeks.

06

What researchers measure

Primary outcomes

  1. Objective Cognition - Computerized Cognitive Tasks

    Complete computerized tasks. These tasks will measure cognitive functions (e.g., processing speed).

    Time frame: Up to 10 weeks

  2. Objective Cognition - Computerized Cognitive Tasks

    Complete computerized tasks. These tasks will measure cognitive functions (e.g., attention).

    Time frame: Up to 10 weeks

  3. Objective Cognition - Computerized Cognitive Tasks

    Complete computerized tasks. These tasks will measure cognitive functions (e.g., executive function).

    Time frame: Up to 10 weeks

  4. Subjective Cognitive Self-Efficacy. -Cognitive Failures Questionnaire

    A 25-item questionnaire. Participants rate from 0 (never) to 4 (very often) frequency of cognitive errors. Higher scores indicate lower cognitive self-efficacy.

    Time frame: Up to 10 weeks

  5. Coronavirus Anxiety Scale

    5- item questionnaire that assess anxiety related to the Coronavirus.

    Time frame: Up to 10 weeks

  6. Anxiety - State-Trait Anxiety Inventory

    Inventory that asks respondents to rate how true 20 self-descriptive statements (e.g., I feel calm) are on a 4-point scale (1 = not at all, 4 = very much so). Typically, respondents are asked to rate statements according to how they generally feel (trait-anxiety scale) and how they feel in the current moment (state-anxiety scale). Total scores range from 20 to 80, with higher scores indicating greater maladjustment.

    Time frame: Up to 10 weeks

Secondary outcomes

  1. Game-related experience- Sessions and duration played

    During the intervention phase the cognitive training group will play games and will need to log the days and duration played.

    Time frame: Up to 10 weeks

  2. Circadian Rhythm- Morningness-Eveningness Questionnaire

    19-item questionnaire that assesses preference for morning, afternoon, and evening activities. Total score reflects degree of "morningness" or "eveningness" type.

    Time frame: Up to 10 weeks

  3. Subjective Arousal- Global Cognitive Arousal-Perceived Stress Scale

    Perceived Stress Scale is a self-report measure of how life situations are perceived as stressful. The scale consists of 15 items corresponding to everyday situation and participants are asked to rate on a likert scale from 0 (never) to 4 (very often) how often they felt or thought a specific way. Higher scores correspond to higher perceived stress.

    Time frame: Up to 10 weeks

  4. Subjective Arousal- Pre-sleep Arousal Scale

    Pre-sleep Arousal Scale is a 16-item self-report questionnaire comprising both cognitive and somatic manifestations of arousal.

    Time frame: Up to 10 weeks

  5. Subjective Arousal- Arousal Predisposition Scale Subjective Arousal- Arousal Predisposition Scale Subjective Arousal- Arousal Predisposition Scale

    Arousal Predisposition Scale is a 12-item inventory that has been designed to measure the degree to which an individual experiences arousal. Higher scores indicate greater predisposition to arousal.

    Time frame: Up to 10 weeks

  6. Game Engagement Questionnaire

    Questionnaire assessing the experience of the game.

    Time frame: Up to 10 weeks

  7. Mood-Depression-Beck Depression Inventory-II

    21-item inventory that asks respondents to rate on a scale of 0 (no depressive feelings) to 3 (most depressive feelings) their feelings towards various aspects of daily living/situations. Higher total scores indicate worse depressive symptoms.

    Time frame: Up to 10 weeks

  8. Alcohol Use - Alcohol Use Disorder Test

    10-item questionnaire that assess the frequency of alcohol use and problems associated with alcohol use over the past year.

    Time frame: Baseline

  9. Physical Activity - International Physical Activity Questionnaire

    7- item questionnaire assessing the different kinds of physical activities that the participant does as pat of their everyday life.

    Time frame: Up to 10 weeks

  10. Personality - Big Five Inventory

    10 question assessment measuring personality.

    Time frame: Baseline

  11. COVID-19 related media exposure and risk questions

    20- item questionnaire assessing the effects of news and social media on perception of COVID-19.

    Time frame: Up to 10 weeks

  12. Subjective Intervention Efficacy- Internet Intervention Utility Questionnaire

    16- item questionnaire about the use of the intervention.

    Time frame: Up to 10 weeks

  13. Computer Proficiency- Computer Proficiency Questionnaire

    This questionnaire asks about participants' ability to perform a number of tasks with a computer. Will be examined as a covariate.

    Time frame: Baseline

  14. Subjective Behavioral Sleep- Insomnia Severity Index

    Brief self-report measure of current perception of insomnia symptom severity, distress and daytime impairment. Commonly used in insomnia treatment outcome research.

    Time frame: Up to 10 weeks

  15. Beck Depression Inventory-2nd Edition

    21-item inventory that asks respondents to rate on a scale of 0 (no depressive feelings) to 3 (most depressive feelings) their feelings towards various aspects of daily living/situations. Higher total scores indicate worse depressive symptoms.

    Time frame: Up to 10 weeks

  16. Subjective Behavioral Sleep - Electronic Daily Sleep Diaries

    Online diaries completed each morning (\~5 mins); diaries measure sleep onset latency, wake time after sleep onset, total sleep time, and sleep quality.

    Time frame: Up to 10 weeks

  17. Subjective Behavioral Sleep - Electronic Daily Sleep Diaries

    Online diaries completed each morning (\~5 mins); diaries measure sleep onset latency

    Time frame: Up to 10 weeks

  18. Subjective Behavioral Sleep - Electronic Daily Sleep Diaries

    Online diaries completed each morning (\~5 mins); diaries measure wake time after sleep onset

    Time frame: Up to 10 weeks

  19. Subjective Behavioral Sleep - Electronic Daily Sleep Diaries

    Online diaries completed each morning (\~5 mins); diaries measure total sleep time

    Time frame: Up to 10 weeks

  20. Subjective Behavioral Sleep - Electronic Daily Sleep Diaries

    Online diaries completed each morning (\~5 mins); diaries measure sleep quality

    Time frame: Up to 10 weeks

07

Study locations

1 site
  • University of Missouri
    Columbia, Missouri 65201, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04421690
Lead sponsor
University of Missouri-Columbia
Responsible party
Ashley Curtis (Assistant Professor, University of Missouri-Columbia) — Principal investigator
First posted
Jun 9, 2020
Start date
Jun 8, 2020
Primary completion
Jun 30, 2022
Completion
Jun 30, 2022
Last update
Mar 15, 2023

Study contacts

Ashley Curtis, PhD
principal investigator · University of Missouri- School of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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